intravenous interleukin-4 pe38kdel cytotoxin in treating patients with recurrent or metastatic kidney cancer, non-small cell lung cancer, or breast cancer

Conditions: Breast Cancer; Kidney Cancer; Lung Cancer

Summary: rationale: interleukin-4 pe38kdel cytotoxin may be able to deliver cancer-killing substances directly to solid tumor cells. purpose: phase i trial to study the effectiveness of intravenous interleukin-4 pe38kdel cytotoxin in treating patients who have recurrent or metastatic kidney cancer, non-small cell lung cancer, or breast cancer that has not responded to previous treatment.

objectives: * determine the maximum tolerated dose of interleukin-4 pe38kdel cytotoxin in patients with recurrent or unresponsive, metastatic renal cell, non-small cell lung, or breast cancer that overexpresses interleukin-4 receptors. * determine the qualitative and quantitative toxic effects of this drug, including the duration and intensity of these toxic effects, in these patients. * determine the pharmacokinetic behavior of this drug in these patients. * determine the antibody response (if any) in patients treated with this drug. * determine, in a preliminary manner, the antitumor activity of this drug in these patients. outline: this is a dose-escalation, multicenter study. patients receive interleukin-4 pe38kdel cytotoxin (nbi-3001) iv over 10 minutes once daily on days 1-5. treatment repeats every 28 days in the absence of disease progression, unacceptable toxicity, or detection of neutralizing antibodies. cohorts of 3-6 patients receive escalating doses of nbi-3001 until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. projected accrual: a maximum of 36 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed recurrent or unresponsive, metastatic renal cell, non-small cell lung, or breast cancer that has been treated previously with standard surgery, radiotherapy, chemotherapy, or immunotherapy or for which no available treatment options currently exist * confirmed overexpression of interleukin-4 receptors * measurable disease (lesions greater than 10 mm by ct scan) or * evaluable disease * no prior or concurrent clinically significant brain metastases * hormone receptor status: * not specified patient characteristics: age: * 18 and over sex: * male or female menopausal status: * not specified performance status: * karnofsky 70-100% life expectancy: * more than 12 weeks hematopoietic: * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin no greater than 1.5 times upper limit of normal (uln) * transaminases no greater than 1.5 times uln * albumin at least 2.5 g/dl * hepatitis b surface antigen negative * hepatitis c antibody negative * no prior or concurrent hepatic disease (e.g., hepatitis or alcoholic liver disease) renal: * creatinine no greater than 2.0 mg/dl cardiovascular: * see surgery * electrocardiogram normal * muga scan normal * no congestive heart failure * no cardiac arrhythmia requiring treatment * no myocardial infarction * no clinical evidence of coronary artery disease (unless there is a cardiac evaluation and evidence of adequate coronary function by a stress test or angiography) other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception for 4 weeks before, during, and for at least 3 months after study * no concurrent underlying medical condition that would preclude study or cannot be controlled * no active infection prior concurrent therapy: biologic therapy: * see disease characteristics chemotherapy: * see disease characteristics * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) endocrine therapy: * not specified radiotherapy: * see disease characteristics * at least 4 weeks since prior radiotherapy surgery: * see disease characteristics * at least 1 year since prior surgery or angioplasty for coronary artery disease other: * at least 28 days since prior experimental drugs and recovered

Keywords: stage iv breast cancer recurrent breast cancer recurrent non-small cell lung cancer stage iv renal cell cancer recurrent renal cell cancer stage iv non-small cell lung cancer male breast cancer